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Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry

Prospective Australasian National Bifurcation Coronary Intervention Outcomes Registry comparing provisional strategy to 2 stent strategy.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12624000143527
Acronym
ABC Registry
Enrollment
15
Registered
2024-02-15
Start date
2023-08-21
Completion date
2028-01-01
Last updated
2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Despite the substantial volume of bifurcation PCI which is performed in ANZ, there is no local registry in which procedural techniques, device usage, and outcomes are documented. The study is observational in nature only, with PCI selection and technique will be left at the discretion of the operator. Eligible subjects will be enrolled into the registry after providing informed consent. Medical records review and phone call follow up will be performed to assess for the incidence of the primary and secondary outcome at 72hrs (medical record only), 3 months, 1 year and 2 years.

Interventions

All patients recruited to this study require a stenting procedure as clinically indicated to coronary disease occurring at a bifurcation. Patients will present with stable angina, acute coronary syndromes, or other indications, and need to have severe coronary disease either angiographically or based on functional assessment. Patient selection and the technique will be left completely at the discretion of the operator, with a provisional (one-stent) technique and a 2-stent technique being the ma

All patients recruited to this study require a stenting procedure as clinically indicated to coronary disease occurring at a bifurcation. Patients will present with stable angina, acute coronary syndromes, or other indications, and need to have severe coronary disease either angiographically or based on functional assessment. Patient selection and the technique will be left completely at the discretion of the operator, with a provisional (one-stent) technique and a 2-stent technique being the main bifurcation stenting sub-groups. Participants will be asked to provide informed consent after being provided a patient information sheet and the opportunity to discuss questions about the study. Patients will receive a phone call at 3 months, 1 year and 2 years to assess if they have any symptoms or presentations to hospital which may indicate target lesion failure.

Sponsors

Northern Sydney Local Health District
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

-18 years and older. -Coronary bifurcation according to the Medina classification of bifurcations (1,1,1; 1,0,0; 1,1,0; 1,0,1; 0,1,1; 0,1,0). -Main branch diameter greater than or equal to 2.5mm and side branch diameter greater than or equal to 2mm. -Lesion severity greater than or equal to 70% stenosis, positive pressure wire assessment (FFR less than or equal to 0.8; iFR<0.9), culprit lesion for ST-elevation myocardial infarction (STEMI) or Non-STEMI (NSTEMI), or positive functional assessment in the territory being revascularized. -Treated with either a provisional or 2 stent strategy. -Treated with drug-eluting stents.

Exclusion criteria

Age less than 18 years Cardiogenic Shock Allergy/intolerance to anti-platelet medication Less than 1 year expected survival Active bleeding disorder

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026